GC Pharma announced Wednesday that it has submitted an application for item permission for an anthrax vaccine, GC1109, co-developed with the Korea Disease Control and Prevention Agency (KDCA), to the Ministry of Food and Drug Safety (MFDS).

GC1109 uses gene recombination technology to create the Protective Antigen (PA) protein. It is "the world's first anthrax vaccine" to utilize this technology, GC Pharma said.

GC Pharma has been developing this anthrax vaccine since 2002 through a research project with the KDCA to prepare for national crises such as bioterrorism.

As anthrax has a high fatality rate, it is difficult to conduct phase 3 clinical trials to confirm the effectiveness of vaccine against anthrax infection in a large number of people.

For this reason, GC Pharma conducted an alternative phase 3 animal test, and showed that high anthrax antibody levels were maintained six months after the fourth dose of the vaccine in an animal model.

After the vaccine was developed, GC Pharma performed clinical trials in healthy adults, and showed that the vaccinated group produced enough antibodies to neutralize the anthrax toxin, the company said.

The World Health Organization (WHO) reported that if 50 kilograms of anthrax spores were released two kilometers in front of an area with a population of 500,000, it was estimated that 125,000 people would become ill and 95,000 would die. In fact, it was used in bioterrorism through the mail in the United States after the September 11 attacks in 2001, infecting 22 people and killing five.

"The challenge of localizing the anthrax vaccine is very significant in terms of securing national public health security," said Heo Eun-cheol, CEO of GC Pharma. "GC Pharma has led the way in localizing essential medicines such as vaccines since its founding, and we will continue to contribute to the stable supply of basic medicines."